Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women

Effect of N-3 Polyunsaturated Fatty Acids Supplementation on the Human Milk Composition of Lactating Women: Nutritional Intervention With Rapeseed Oil and n-3 Margarine Compared to Standard Olive Oil

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288313

Acronym

Oméga 3

Enrollment

Registered

2011-02-02

Start date

2011-09-01

Completion date

2013-12-01

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nursing Women

Keywords

human milk, polyunsaturated fatty acids, linolenic acid, rapeseed oil

Brief summary

We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women

Detailed description

n-3 and n-6 long chain polyunsaturated fatty acids (LCPUFA) are essential particularly to neurodevelopment of newborn infants. Many variations in essential PUFA and LCPUFA content of human milk are observed according to countries and dietary habits of the mothers. Maternal diet supplementation of LCPUFA of lactating women may increase LCPUFA human milk according to consensus recommendations. This clinical trial is performed to evaluate the effect of different of consumption of n-3 fatty acids (linolenic acid) in different forms (oils or margarine) in the human milk composition. Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will be randomised into four groups : one group will receive olive oil (standard group), one group supplemented in rapeseed oil, one group with n-3 margarine and one group with diet associating rapeseed oil and n-3 margarine.Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.

Interventions

DIETARY_SUPPLEMENTnutritional intervention

Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive 30gr/day rapeseed oil. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Lactating women more than 1 month and less than 4 month with neonate whom term is between 37 and 42 gestational age * Women who agree to consume fatty fish two times per week * Free consent

Exclusion criteria

* Women with multiple infants * Chronic treatments more than 8 days * Women with treatment during supplementation period * Women with maternal pathology not compatible with breastfeed

Design outcomes

Primary

Measure	Time frame
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15	30 days

Secondary

Measure	Time frame
Analysis of linolenic acid and linoleic acid ratio	30 days
Analysis of arachidonic acid, docosahexanoic acid and their ratio	30 days
Comparison of fatty acid composition of human milk before and after supplementation	30 days
Analysis of trans fatty acids according diets	30 days

Countries

France

Contacts

STUDY_CHAIRPaul PEREZ, MD, PhD

University Hospital Bordeaux (France)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026